Entecavir
Dosing in kidney impairment
Renal Impairment In adult subjects with renal impairment, the apparent oral clearance of entecavir decreased as creatinine clearance decreased [see Clinical Pharmacology ] . Dosage adjustment is recommended for patients with creatinine clearance less than 50 mL/min, including patients on hemodialysis or continuous ambulatory peritoneal dialysis (CAPD), as shown in Table 2.
The once-daily dosing regimens are preferred. [See table below.] Although there are insufficient data to recommend a specific dose adjustment of entecavir in pediatric patients with renal impairment, a reduction in the dose or an increase in the dosing interval similar to adjustments for adults should be considered.
| Creatinine Clearance (mL/min) | Usual Dose (0.5 mg) | Lamivudine-Refractory or Decompensated Liver Disease (1 mg) |
|---|---|---|
| a For doses less than 0.5 mg, entecavir Oral Solution is recommended. b If administered on a hemodialysis day, administer entecavir after the hemodialysis session. | ||
| 50 or greater | 0.5 mg once daily | 1 mg once daily |
| 30 to less than 50 | 0.25 mg once daily a OR 0.5 mg every 48 hours | 0.5 mg once daily OR 1 mg every 48 hours |
| 10 to less than 30 | 0.15 mg once daily a OR 0.5 mg every 72 hours | 0.3 mg once daily a OR 1 mg every 72 hours |
| Less than 10 Hemodialysis b or CAPD | 0.05 mg once daily a OR 0.5 mg every 7 days | 0.1 mg once daily a OR 1 mg every 7 days |
Dosing in liver impairment
Recommended Dosage in Adults Compensated Liver Disease The recommended dose of entecavir for chronic hepatitis B virus infection in nucleoside-inhibitor-treatment-naïve adults and adolescents 16 years of age and older is 0.5 mg once daily. The recommended dose of entecavir in adults and adolescents (at least 16 years of age) with a history of hepatitis B viremia while receiving lamivudine or known lamivudine or telbivudine resistance substitutions rtM204I/V with or without rtL180M, rtL80I/V, or rtV173L is 1 mg once daily.
Decompensated Liver Disease The recommended dose of entecavir for chronic hepatitis B virus infection in adults with decompensated liver disease is 1 mg once daily.
Hepatic Impairment No dosage adjustment is necessary for patients with hepatic impairment.
Preparation and administration
Timing of Administration Entecavir should be administered on an empty stomach (at least 2 hours after a meal and 2 hours before the next meal).